Effectivity of Postpartum Dexamethasone for Women With Class I HELLP Syndrome (COHELLP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Instituto Materno Infantil Prof. Fernando Figueira
Sponsor:
Information provided by (Responsible Party):
Leila Katz, Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier:
NCT00711841
First received: July 7, 2008
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

Corticotherapy accelerates maternal postpartum recovery in women with class I HELLP syndrome. The benefit of faster and better recovery would be observed in fewer complications, less utilization of blood products and shorter hospital stay.


Condition Intervention Phase
HELLP Syndrome
Drug: dexamethasone
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postpartum Dexamethasone for Women With Class I HELLP Syndrome: a Double-blind, Placebo-controled, Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Instituto Materno Infantil Prof. Fernando Figueira:

Primary Outcome Measures:
  • severe maternal morbidity [ Time Frame: postpartum ] [ Designated as safety issue: No ]
    42 days after delivery


Secondary Outcome Measures:
  • hospital stay duration [ Time Frame: postpartum ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: July 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: saline solution
Placebo (saline solution), 2 mL, intravenous, every 12 hours, for 48 hours
Drug: dexamethasone
Dexamethasone, 10mg (2mL), intravenous, every 12 hours, for 48 hours
Drug: Placebo
Saline solution, 2 mL, intravenous, every 12 hours, for 48 hours
Active Comparator: Dexamethasone
Dexamethasone, 10mg (2mL), intravenous, every 12 hours, for 48 hours
Drug: dexamethasone
dexamethasone, 10mg, 2 mL, intravenous solution, every 12 hours , for 48 hours

Detailed Description:

Patients with Class I HELLP Syndrome will be recruited for use os dexamethasone or placebo in the puerperium. Effects such as clinical course (blood pressure and diureses), laboratorial behaviour and complications will be compared. Duration of hospitalization will also be accessed.

  Eligibility

Ages Eligible for Study:   13 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postpartum women with Class I HELLP syndrome

Exclusion Criteria:

  • Chronic users of corticosteroids
  • Patients with chronic conditions affecting the laboratory parameters involved in the HELLP syndrome
  • Women who had received antenatal corticosteroids to treat HELLP syndrome were excluded
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00711841

Contacts
Contact: Leila Katz, pHD 55 81 21224739 ext 4739 katzleila@gmail.com
Contact: Melania M Amorim, pHD 55 83 88221514 melania.amorim@gmail.com

Locations
Brazil
Instituto Materno Infantil Prof. Fernando Figueira Recruiting
Recife, Pernambuco, Brazil, 50.070-550
Contact: Leila Katz, pHD    55 81 21224739 ext 4739    katzleila@yahoo.com.br   
Sponsors and Collaborators
Instituto Materno Infantil Prof. Fernando Figueira
Investigators
Principal Investigator: Leila Katz, pHD IMIP
  More Information

No publications provided by Instituto Materno Infantil Prof. Fernando Figueira

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Leila Katz, Obstetrical ICU obstetrical coordinator; MD , PhD, Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier: NCT00711841     History of Changes
Other Study ID Numbers: IMIFernando Figueira
Study First Received: July 7, 2008
Last Updated: May 28, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Instituto Materno Infantil Prof. Fernando Figueira:
HELLP syndrome
dexamethasone
postpartum period
class I HELLP syndrome

Additional relevant MeSH terms:
HELLP Syndrome
Syndrome
Disease
Hypertension, Pregnancy-Induced
Pathologic Processes
Pregnancy Complications
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014